Panuel Tablets 2.5 mg (Letrozole)

Adult dose

○ Adults and elderly patients: The recommended dose is 2.5 mg of letrozole orally once daily, regardless of meals. If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not take a double dose to make up for a missed dose; do not exceed the recommended dose of 2.5 mg. For patients with metastatic disease, treatment should continue until disease progression is confirmed. For adjuvant therapy and extended adjuvant therapy following adjuvant tamoxifen, treatment may be given for 5 years. If cancer recurs during treatment, discontinue the drug (for extended adjuvant therapy following adjuvant tamoxifen, the optimal duration of treatment associated with long-term use has not been established.). ○ Patients with hepatic impairment: Although blood concentrations of this drug are slightly increased in patients with moderate hepatic impairment due to cirrhosis, no dose adjustment is needed in patients with mild to moderate hepatic impairment. However, patients with severe hepatic impairment (Child-Pugh score C) should be treated with this drug under continuous and close supervision. ○ Patients with renal impairment: No dose adjustment is needed in patients with renal impairment and a creatinine clearance of 10 mL/min or higher.

This medicine is an estrogen suppressant primarily used for the treatment of breast cancer in postmenopausal women. This medicine should not be used by individuals who are allergic to this medication or its components, premenopausal women, pregnant or potentially pregnant women, and nursing mothers. Patients with severely impaired renal function or severe liver dysfunction need careful consideration before administration, while those with a history of osteoporosis or a high risk of fractures should regularly monitor their bone density and manage their bone health. Patients with uncertain menopausal status should check hormone levels before taking this medication and should only take it if in a postmenopausal state. As this medicine is primarily metabolized in the liver, patients with liver function abnormalities should undergo regular liver function tests, and discontinuation might be necessary if liver function worsens. During treatment, symptoms like flushing, arthralgia, nausea, fatigue, and hair loss may occur, which can be normal side effects due to estrogen deficiency. Cardiovascular abnormalities such as thrombosis, heart failure, and angina may arise; if symptoms appear, immediate consultation with a healthcare professional is advised. As this medicine is metabolized by specific liver enzymes (CYP3A4, CYP2A6), caution is needed when used in conjunction with drugs that inhibit or induce these enzymes, as it may alter blood concentrations. Exposure to this medicine during pregnancy poses a serious risk to the fetus, so women who could become pregnant must confirm their menopausal status and, if necessary, use appropriate contraceptive methods. This medication has not been established as safe and effective in children under 17 years of age, and should not be used in this population. No dosage adjustment is necessary for the elderly, but caution is advised due to an increased risk of fractures. In case of overdose, symptomatic treatment and monitoring of vital signs is necessary as there is no specific antidote; in emergencies, inducing vomiting may be considered. This medicine should be kept out of reach of children and should not be stored outside of its original container. Regular checks for decreased bone density and prevention of osteoporosis are recommended during treatment, and liver function and cardiovascular status should be regularly monitored. Dizziness or drowsiness may occur during driving or operating machinery, so caution is advised.

• urinary tract infection
• pain from mass
• leukopenia
• anaphylactic-like reaction
• hypercholesterolemia
• loss of appetite
• increased appetite
• depression
• anxiety
• hypersensitivity

This medicine should be stored in a tightly closed container to protect it from air and moisture. It is also recommended to store it in a cool place at a temperature below 30 degrees Celsius.

Appearance

Dark yellow, round, film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)